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Instant hand sanitizer - Medication Information

Product NDC Code 61010-1112
Drug Name

Instant hand sanitizer

Type Brand
Active Ingredients
Alcohol 665 ml/l
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 616762
Application Number 505G(a)(3)
Labeler Name Safetec of America
Packages
Package NDC Code Description
61010-1112-2 25 pouch in 1 box (61010-1112-2) / .034 l in 1 pouch (61010-1112-1)
61010-1112-3 144 pouch in 1 box (61010-1112-3) / .034 l in 1 pouch (61010-1112-1)
61010-1112-8 10 pouch in 1 box (61010-1112-8) / .034 l in 1 pouch (61010-1112-1)
61010-1112-0 .046 l in 1 bottle (61010-1112-0)
61010-1112-5 .118 l in 1 bottle (61010-1112-5)
61010-1112-6 .237 l in 1 bottle, pump (61010-1112-6)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Ethyl Alcohol 66.5%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions wet hands & wrists thoroughly with product and allow to dry without wiping

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses For handwashing to decrease bacteria on skin without soap and water

Purpose

Information about the drug product’s indications for use.
Purpose Antiseptic

Spl product data elements

Usually a list of ingredients in a drug product.
Instant Hand Sanitizer alcohol ALOE WATER TROLAMINE ALCOHOL ALCOHOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label Safetec A.B.H.C. ™ MEETS CDC HANDWASHING RECOMMENDATIONS Instant Hand Sanitizer 0.9 g (1/32 oz.) Safetec of America, Inc. Buffalo, NY 14215 800-456-7077 PRINCIPAL DISPLAY PANEL – 0.9g Pouch Label PRINCIPAL DISPLAY PANEL – 144 Packets Box Label NDC 61010-1112-3 Safetec Infection Control Instant Hand Sanitizer Fresh Scent Instant Hand Sanitizer with Aloe Vera A.B.H.C. ™ MEETS CDC HANDWASHING RECOMMENDATIONS 144 Packets Each Packet Net. Wt. 0.9g PRINCIPAL DISPLAY PANEL – 144 Packets Box Label

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use in eyes, if this happens, rinse thoroughly with water.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use, ask a doctor if irritation develops and persists for 72 hours. If ingested, get medical help or contact a Poison Control Center right away.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only Flammable, keep away from fire or flame. Keep out of reach of children. Do not use in eyes, if this happens, rinse thoroughly with water. Stop use, ask a doctor if irritation develops and persists for 72 hours. If ingested, get medical help or contact a Poison Control Center right away.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API